CN105687509A - 一种用于治疗仔猪白痢的药物组合物及其制备方法 - Google Patents
一种用于治疗仔猪白痢的药物组合物及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种用于治疗仔猪白痢的药物组合物及其制备方法,其药物组合物包括以下原料药材:黄荆子、马尾连、地锦草、墓头回、仙茅参、岩青兰、苘实、海金沙、水蓼、赤车使者、佩兰、仙鹤草、分心木、管仲、牛西西、紫菀、刺石榴、十大功劳叶、何首乌、土丁桂、牡荆叶和倒赤伞。本发明的有益效果是:本发明的药物组具有清热解毒、燥湿调气和血,另外,还能够增强其抵抗能力,在治疗仔猪黄白痢疾方面,具有疗效高,见效快,低毒性,提高猪的免疫力等优势。
Description
技术领域
本发明涉及兽药领域,特别涉及一种用于治疗仔猪白痢的药物组合物及其制备方法。
背景技术
仔猪白痢(Whitescourofpiglets)由大肠杆菌引起的10~30日龄以内仔猪的常发疾病。临诊症状以下痢、排出灰白色粥状粪便为特征。在剖检上主要为卡他性胃肠炎变化。仔猪白痢一般是指主要由大肠杆菌引起的,所以又叫仔猪大肠杆菌病。
引起仔猪白痢的因素为:细菌性原因:主要是由血清型O8:K88的大肠杆菌引起,066、O115、O141,0149,0149、O2、O45血清型次之。有的地方与引起仔猪黄痢、猪水肿病的血清型相同。有的地方还有另外一些血清型的大肠杆菌引起。其他原因:仔猪白痢的发生,除了上述大肠杆菌外,还与日龄、免疫状态、生理机能、饲养管理及多种应激因素造成的消化机能紊乱有关。在多种不利因素影响下,仔猪消化道食物分解不全的产物或由于发酵产生低级脂肪酸,刺激肠蠕动加快而引起下泻;病猪消化道机能紊乱,肠道菌群失调,内环境遭到破坏,有害细菌迅速增殖,引起肠道炎症,促使肠黏膜大量分泌,加重腹泻过程。
仔猪白痢主要症状:粪便为白色、灰白色或黄白色,粥样、糊状,有腥臭味。有时粪便中混有气泡。如不及时采取预防措施,下痢可逐渐加剧,肛门周围、尾及后肢常被稀粪沾污,仔猪精神委顿、食欲废绝、消瘦、走路不稳、寒战,喜钻卧垫料或挤压成堆。如并发肺炎则有咳嗽和呼吸加快。若治疗不及时或治疗不当,常经5~6天死亡。也有病期延长到2~3周以上的。病程较长而恢复的仔猪生长发育缓慢,甚至成为僵猪。
仔猪白痢的病理因素:病死仔猪脱水,消瘦、皮肤苍白。胃粘膜充血、水肿,肠内容物灰白色,酸臭或混有气泡。肠壁变薄半透明,肠粘膜充血、出血易剥脱,肠系膜淋巴结肿胀,常有继发性肺炎病变。
中兽医学理论认为,大肠杆菌引起的白痢一是胎毒过盛;二是热乳所伤,三是母猪过食或饲料变更,四是天气骤变、寒热侵袭等引起。
目前治疗仔猪白痢主要依预防为主:应采取抗菌、止泻,中药解除湿热内因、提高免疫力、使肠道内环境正常液等综合措施。清热燥湿止痢:四黄止痢颗粒,预防量100g拌料300斤,治疗量加倍使用,连续用5-7天。抗菌:安普霉素、链霉素、环丙沙星、恩诺沙星阿莫西林、泻停。如1.痢菌净按每公斤体重每次10-15mg口服,每日2次,连用2-3天;2.硫酸庆大霉素每次5-10mg/kg体重口服,每日2次,连用2-3天止泻:鞣酸蛋白。助消化吸收:食母生、小苏打、胃蛋白酶等。补液:口服葡萄糖生理盐水及多维。葡萄糖生理盐水的配方:1000ml水中加葡萄糖20克,氯化钠3.5克,氯化钾1.5克,碳酸氢钠2.5克。
西医常用药物:阿托品、凯诺肠移建、核酸肽、鞣酸蛋白、庆大霉素、促菌生、调菌生、乳康生、康大宝等。上述治疗方案、药品均有限,达不到理想的治疗效果,并且治疗成本较高。
发明内容
本发明所要解决的技术问题是在于提供一种用于治疗仔猪白痢的药物组合物,本发明的药物组具有清热解毒、燥湿、调气和血,另外,还能够增强其抵抗能力,在治疗仔猪黄白痢疾方面,具有疗效高,见效快,低毒性,提高猪的免疫力等优势。
为了实现上述发明目的,本发明提供了一种用于治疗仔猪白痢的药物组合物,所述药物组合物包括以下原料药材:所述药物组合物包括以下原料药材:黄荆子、马尾连、地锦草、墓头回、仙茅参、岩青兰、海金沙、水蓼、赤车使者、佩兰、仙鹤草、牛西西、紫菀、刺石榴、何首乌、土丁桂和牡荆叶。
所述药物组合物中各原料药材的重量份数比为:黄荆子12-22重量份、马尾连15-35重量份、地锦草13-27重量份、墓头回17-36重量份、仙茅参14-28重量份、岩青兰15-32重量份、海金沙11-21重量份、水蓼14-24重量份、赤车使者15-35重量份、佩兰13-31重量份、仙鹤草15-45重量份、牛西西13-27重量份、紫菀14-36重量份、刺石榴15-40重量份、何首乌18-32重量份、土丁桂10-20重量份和牡荆叶12-42重量份。
所述药物组合物中各原料药材的重量份数比为:黄荆子18重量份、马尾连33重量份、地锦草25重量份、墓头回34重量份、仙茅参16重量份、岩青兰31重量份、海金沙17重量份、水蓼22重量份、赤车使者34重量份、佩兰27重量份、仙鹤草42重量份、牛西西25重量份、紫菀34重量份、刺石榴40重量份、何首乌20重量份、土丁桂15重量份和牡荆叶30重量份。
所述药物组合物还包括:分心木、管仲、苘实、十大功劳叶和倒赤伞。
所述药物组合物中各原料药材的重量份数为:黄荆子12-22重量份、马尾连15-35重量份、地锦草13-27重量份、墓头回17-36重量份、仙茅参14-28重量份、岩青兰15-32重量份、海金沙11-21重量份、水蓼14-24重量份、赤车使者15-35重量份、佩兰13-31重量份、仙鹤草15-45重量份、牛西西13-27重量份、紫菀14-36重量份、刺石榴15-40重量份、何首乌18-32重量份、土丁桂10-20重量份、牡荆叶12-42重量份、分心木15-25重量份、管仲13-37重量份、苘实10-20重量份、十大功劳叶12-34重量份和倒赤伞13-27重量份。
所述药物组合物中各原料药材的重量份数为:黄荆子18重量份、马尾连33重量份、地锦草25重量份、墓头回34重量份、仙茅参16重量份、岩青兰31重量份、海金沙17重量份、水蓼22重量份、赤车使者34重量份、佩兰27重量份、仙鹤草42重量份、牛西西25重量份、紫菀34重量份、刺石榴40重量份、何首乌20重量份、土丁桂15重量份、牡荆叶30重量份、分心木22重量份、管仲34重量份、苘实12重量份、十大功劳叶28重量份和倒赤伞15重量份。
所述药物组合物的剂型为粉针剂,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量3~5倍的醇浓度为85%~95%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在5℃~10℃的条件下静置24~36小时,采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎40~60分钟,获得0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料10g~20g,加入丙二醇30g~50g,加200ml注射用水,搅拌使其溶解,进一步加注射用水至1000ml,再加入1g~1.5g针用活性炭,充分搅拌30~50分钟;脱炭过滤;用0.22~0.24μm微孔滤膜过滤;冷冻干燥得无菌粉末,分装灌封。
所述药物组合物的剂型为散剂,其制备方法包括以下步骤:
第一步,将墓头回、仙茅参、岩青兰、海金沙、水蓼、赤车使者和佩兰按所述比例混合,用相对于获得的混合物质量的3~5倍的醇浓度为85%~95%的乙醇溶解,加热回流2~4小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的1~2倍的醇浓度85%~95%的乙醇溶解,加热回流1~2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为0.7~0.9g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为90%~95%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将刺石榴、何首乌、土丁桂和牡荆叶按所述比例混合,加相对于获得的混合物质量的2~4倍的醇浓度85%~95%的乙醇,加热回流提取1~2次,提取液合并,用管式离心机离心除杂,将除杂后的提取液于60℃~70℃的条件下减压浓缩至60℃时相对密度为1.20~1.23的膏体,将浓缩后的膏体用喷雾干燥器干燥成粉末;
第三步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的2~4倍的水溶解,加热煎煮2~4小时,过滤;将滤渣再次用相对于获得的混合物质量的1~2倍的水溶解,再次加热煎煮1~2小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第四步,将第一步、第二步和第三步获得的粉末混合,随后过筛成80~120目的细粉,将获得的细粉投入混合搅拌机中搅拌,即获得散剂。
本发明的有益效果是:本发明的药物组具有清热解毒、燥湿、调气和血,另外,还能够增强其抵抗能力,在治疗仔猪黄白痢疾方面,具有疗效高,见效快,低毒性,提高猪的免疫力等优势。
具体实施方式
本发明的药物组合物遵循清热解毒、燥湿、调气和血的原则,提供了一种用于治疗仔猪白痢的药物组合物,包括以下原料药材:黄荆子、马尾连、地锦草、墓头回、仙茅参、岩青兰、苘实、海金沙、水蓼、赤车使者、佩兰、仙鹤草、分心木、管仲、牛西西、紫菀、刺石榴、十大功劳叶、何首乌、土丁桂、牡荆叶和倒赤伞。
上述各原料药材的药理特性如下:
倒赤伞:来源:菊科倒赤伞Ainsliaealatifolia(D.Don)Sch.-Bip.,以全草入药。性味:辛、苦,温。主治:祛风散寒,止咳,止痢。治风寒咳嗽、肠炎、痢疾等症。
土丁桂:别名:白毛将、银丝草、毛棘草。来源:旋花科土丁桂属植物土丁桂EvolvnlusalsinoidesL.,以全草入药。秋季采集,晒干或鲜用。性味:苦、涩,平。主治:止咳平喘,清热利湿,散淤止痛。用于支气管哮喘,咳嗽,黄疸,胃痛,消化不良,急性肠炎,痢疾,泌尿系感染,白带,跌打损伤,腰腿痛。
管仲:出处:《滇南本草》。别名:番白叶(《滇南本草》),翻白地榆、槟榔仁(《滇南本草》)整理本),翻背白草、白头翁、涩疙瘩(《贵州民间药物》),地管子(《云南思茅中草药选》),地摈榔、白地榆(《云南中草药选》)。来源:为蔷薇科植物亮叶委陵菜的根或带根全草。性味:①《滇南本草》:"性寒,味苦涩。"②《云南思茅中草药选》:"苦涩,平。"主治:清热消炎,凉血止血。治赤白痢疾,肠炎,胃痛,肺结核咯血,鼻衄,便血,血崩,外伤出血,疔疮。①《滇南本草》:"治血崩,白带,大肠下血,用新瓦焙;治面寒疼,烧酒为引。"②《贵州民间药物》:"治痢疾,疔疮,风湿。"③《云南思茅中草药选》:"清热止血,消炎收敛。治痢疾,肠炎,胃痛,咯血,吐血,外伤出血,痛经。"④《云南中草药选》:"凉血止血,收敛止泻。治肺结核咯血,吐血,鼻衄,消化不良,贫血,赤白痢疾。"
刺石榴:别名:山石榴。来源:蔷薇科蔷薇属植物峨眉蔷薇RosaomeiensisRolfe,以果入药。果成熟时采,去果柄及宿萼,晒干。性味:微酸、苦,平。主治:止血,止痢。用于吐血,衄血,崩漏,白带,痢疾。
赤车使者:别名:鹿角七、细水麻叶、石边采、小白沙。来源:为荨麻科楼梯草属植物大伞楼梯草ElatostemaumbellatumBlumevar.majusMaxim.[E.involucratumFranch.etSav.],以全草入药。夏秋采收,晒干备用。性味:微苦,平。主治:清热利湿,活血,消肿。用于细菌性痢疾;外用治风湿关节痛,骨折,痈疖肿毒。
仙鹤草:别名:龙芽草、脱力草、狼牙草、金顶龙牙、黄龙尾、毛脚茵。来源:本品为蔷薇科植物龙牙草AgrimoniapilosaLedeb.的干燥地上部分。夏、秋二季茎叶茂盛时采割,除去杂质,干燥。性味:苦、涩,平。归经:归心、肝经。主治:收敛止血,截疟,止痢,解毒。用于咳血,吐血,崩漏下血,疟疾,血痢,脱力劳伤,痈肿疮毒,阴痒带下。
苘实:出处:《唐本草》。别名:顷麻子(《产乳集验方》),茼麻子(《圣济总录》),空麻子(《江苏植药志》),磨盘树子(《江西民间草药》)。来源:为锦葵科植物苘麻的种子。秋季果实成熟时采收。割取地上部分,晒干后,打下种子,筛去果皮及杂质,贮藏于干燥处。性味:《唐本草》:"味苦,平,无毒。"主治:治赤白痢疾,眼翳,痈肿,瘰疬。①《唐本草》:"主赤白冷热痢,散服饮之;吞一枚,破痈肿。"②《纲目》:"主眼翳瘀肉,起倒睫拳毛。"
墓头回:别名:追风箭、脚汗草、铜班道、虎牙草、摆子草。来源:败酱科败酱属植物异叶败酱PatriniaheterophyllaBunge及糙叶败酱(山败酱)P.scabraBunge,以根或全草入药。秋季采根,去净泥土,晒干。性味:苦、微酸、涩,凉。主治:清热燥湿,止血,止带,截疟。用于子宫糜烂,早期宫颈癌,白带,崩漏,疟疾。
马尾连:别名:马尾黄连。来源:为毛茛科唐松草属植物多叶唐松草ThalictrumfoliolosumDC.及高原唐松草T.cultratumWall.[T.deciternatumBoiv],以根部入药。春、秋季将根挖出,剪去地上茎叶,洗去泥土,晒干。性味:苦,寒。主治:清热燥湿,泻火解毒。用于肠炎,痢疾,黄疸,目赤肿痛。
海金沙:别名:金沙藤、左转藤、蛤蟆藤、罗网藤、铁线藤、吐丝草、鼎擦藤、猛古藤。来源:本品为海金沙科植物海金沙Lygodiumjaponicum(Thunb.)Sw.的干燥成熟孢子。秋季孢子未脱落时采割藤叶,晒干,搓揉或打下孢子,除去藤叶。性味:甘、咸,寒。归经:归膀胱、小肠经。主治:清利湿热,通淋止痛。用于热淋,砂淋,石淋,血淋,膏淋,尿道涩痛。
十大功劳叶:出处:《本草再新》。别名:功劳叶(《饮片新参》)。来源:为小檗科植物阔叶十大功劳、细叶十大功劳或华南十大功劳的叶。秋季采收。性味:《饮片新参》:"苦,凉。"归经:本草再新》:"入肺经。"主治:清热补虚,止咳化痰。治肺痨咳血,骨蒸潮热,头晕耳鸣,腰酸腿软,心烦,目赤。《西藏常用中草药》:"治湿热痢疾,目赤肿痛,痈肿疮毒。"
牛西西:来源:为蓼科酸模属多种植物的统称。除皱叶酸模、羊蹄和齿果酸模外,尚有巴天酸模RumexpatientiaL.,乳突叶酸模R.chalepensisMill.和窄叶酸模R.stenophyllusLedeb.均以根入药。春、秋挖根,除去茎叶,洗净,切片晒干备用。性味:苦、酸,寒。主治:凉血止血,清热解毒,杀虫。用于功能性子宫出血,吐血,咯血,鼻衄,牙龈出血,尾、十二指肠出血,便血,紫癜,便秘,水肿;外用治疥癣,疮疖,脂溢性皮炎。
仙茅参:出处:《陕西植药调查》。别名:茅草细辛(《贵州民间方药集》),毛草七、倒扎草根(《贵州民间药物》),条参、水防风、丝茅七(《陕西中草药》)。来源:为菊科植物白茎鸦葱的根。夏、秋季挖,洗净,晒干或蒸后晒干,亦可鲜用。性味:《陕西中草药》:"味甘,性温。"主治:祛风除湿,理气活血。
牡荆叶:出处:《别录》。来源:为马鞭草科植物牡荆的叶片。性味:辛苦,平。①《别录》:"味苦,平,无毒。"②《纲目》:"苦,寒,无毒。"主治:祛风解表,除湿,杀虫,止痛。治风寒感冒,痧气腹痛吐泻,痢疾,风湿痛:脚气,流火,痈肿,足癣。①《别录》:"主久痢,霍乱转筋,血淋,下部疮,湿匿薄脚,主脚气肿满。"②《福建中草药》:"祛风解表,调气和胃。"
紫菀:出处:《本经》。别名:青菀(《吴普本草》),紫蒨(《别录》),返魂草根、夜牵牛(《斗门方》),紫菀茸(《本草述》)。来源:为菊科植物紫菀的根及根茎。春、秋均可采挖,除去茎叶及泥土,晒干,或将须根编成小辫晒干,商品称为"辫紫菀"。性味:苦,温。①《本经》:"味苦,温。"②《别录》:"辛,无毒。"③《药性论》:"味苦,平。"④《本草通玄》:"辛甘,微温。"归经:入肺经。①《雷公炮制药性解》:"入心、肺二经。"②《本草经疏》:"入手太阴,兼入足阳明。"主治:温肺,下气,消痰,止咳。治风寒咳嗽气喘,虚劳咳吐脓血,喉痹,小便不利。①《本经》:"主咳逆上气,胸中寒热结气,去蛊毒、痿蹷,安五藏。"②《别录》:"疗咳唾脓血,止喘悸,五劳体虚,补不足,小儿惊痫。"③《药性论》:"补虚下气,治胸胁逆气,劳气虚热。"④《唐本草》:"治气喘,阴痿。"⑤《日华子本草》:"调中及肺痿吐血,消痰止咳。"⑥《本草衍义》:"益肺气。"⑦王好古:"主息贲。"⑧宁原《食鉴本草》:"主肺经虚热,开喉痹,取恶涎。"⑨《本草从新》:"专治血痰,为血劳圣药。又能通利小肠。"
佩兰:别名:兰草、泽兰、圆梗泽兰、省头草。来源:本品为菊科植物佩兰EupatoriumfortuneiTurcz.的干燥地上部分。夏、秋二季分两次采割,除去杂质,晒干。性味:辛,平。归经:归脾、胃、肺经。主治:芳香化湿,醒脾开胃,发表解暑。用于湿浊中阻,脘痞呕恶,口中甜腻,口臭,多涎,暑湿表症,头胀胸闷。
地锦草:别名:奶浆草、铺地锦、铺地红、血见愁、卧蛋草、雀儿卧蛋、小虫儿卧蛋。来源:本品为大戟科植物地锦EuphorbiahumifusaWilld.或斑地锦EuphorbiamaculataL.的干燥全草。夏、秋二季采收,除去杂质,晒干。性味:辛,平。归经:归肝、大肠经。主治:清热解毒,凉血止血。用于痢疾,泄泻,咳血,尿血,便血,崩漏,疮疖痈肿。
水蓼:出处:《唐本草》。别名:蔷、虞蓼(《尔雅》),泽蓼(《尔雅》郭璞注),辣蓼草(《本草求原》),柳蓼、川蓼(《植物学大辞典》),水红花(《昆明药植调查报告》),药蓼子草、红蓼子草(《重庆草药》),白辣蓼(《中国药植图鉴》),胡辣蓼(《东北植药图志》),痛骨消(《广西药植名录》),红辣蓼(《常用中草药彩色图谱》),假辣蓼,斑蕉萆(《广西中草药》),水辣蓼、小叶辣蓼(《浙江民间常用草药》)。来源:为蓼科植物水蓼的全草。秋季开花时采收,晒干。性味:辛,平。①《千金·食治》:"辛。"②《日华子本草》:"味辛,冷,无毒。"③《纲目》:"蓼叶,辛,温,无毒。"④《本草求原》:"苦湿,平。"主治:化湿,行滞,祛风,消肿。治痧秽腹痛,吐泻转筋,泄泻,痢疾,风湿,脚气,痈肿,疥癣,跌打损伤。
岩青兰:出处:《高原中草药治疗手册》。别名:哈敦-毕日阳古(蒙名),那乌黄乃(藏名)。来源:为唇形科植物岩青兰的全草。7~8月采全草,洗净,晒干。性味:甘辛,凉。①《高原中草药治疗手册》:"辛,凉。"②《内蒙中草药》:"甘苦,平。"归经:《高原中草药治疗手册》:"入肺、胃、脾三经。"主治:清热消炎,凉血止血。治外感风热,头痛寒热,喉痛,咳嗽,黄疸型肝炎,吐血,衄血,痢疾。①《高原中草药治疗手册》:"解热消炎。治风热头痛,喉痛咳嗽,外感夹食,胸脘胀满。"②《内蒙古中草药》:"清热燥湿,凉肝止血。治头痛,黄疸,吐血,衄血,咽痛,痢疾。"
何首乌:别名:首乌、赤首乌、铁秤砣、红内消。来源:本品为蓼科植物何首乌PolygonummultiflorumThunb.的干燥块根,其藤茎称“夜交藤”。秋、冬二季叶枯萎时采挖,削去两端,洗净,个大的切成块,干燥。性味:苦、甘、涩,温。归经:归肝、心、肾经。主治:解毒,消痈,润肠通便。用于瘰疠疮痈,风疹瘙痒,肠燥便秘;高血脂。
分心木:别名:核桃种隔。来源:本品为胡桃科植物胡桃JuglansregiaL.的木质隔膜。性味:苦、涩,平。主治:补肾涩精。用于肾虚遗精,滑精,遗尿。
黄荆子:出处:《纲目拾遗》。别名:布荆子(《本草求原》),黄金子(《浙江中药手册》)。来源:为马鞭草科植物黄荆的果实。秋季果实成熟时采收,用手搓下,晒干,扬净。性味:辛苦,温。①《草木便方》:"苦,温。"②《南宁市药物志》:"辛,温。"③《广西中药志》:"味辛,性温,无毒。"主治:祛风,除痰,行气,止痛。治感冒,咳嗽,哮喘,风痹,疟疾,胃痛,疝气,痔漏。①《玉环志》:"消食下气。"②《草木便方》:"养肝剧窍,坚齿,聪耳明目。止带浊。疗风痹,颓疝。"③《广州植物志》:"祛风、涤痰、镇咳。""用代茶叶,有解暑之功。"④《南宁市药物志》:"温经散瘀,解肌发汗。治感冒,疟疾,哮喘。"⑤《四川中药志》:"养肝除风,行气止痛。治伤寒呃逆,咳喘,食滞,小肠疝气及痔漏生管。"
以下采用实施例来详细说明本发明的实施方式,借此对本发明如何应用技术手段来解决技术问题,并达成技术效果的实现过程能充分理解并据以实施
实施例1药物组合物1
本发明实施例提供了一种用于治疗仔猪白痢的药物组合物,由以下重量份数的原料药材制成:黄荆子18重量份、马尾连33重量份、地锦草25重量份、墓头回34重量份、仙茅参16重量份、岩青兰31重量份、海金沙17重量份、水蓼22重量份、赤车使者34重量份、佩兰27重量份、仙鹤草42重量份、牛西西25重量份、紫菀34重量份、刺石榴40重量份、何首乌20重量份、土丁桂15重量份和牡荆叶30重量份。
其制备方法如下:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成0.7μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量4倍的醇浓度为85%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在7℃的条件下静置32小时,采用渗漉法以每分钟2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎50分钟,获得0.5μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料15g,加入丙二醇40g,加200ml注射用水,搅拌使其溶解,进一步加注射用水至1000ml,再加入1.5g针用活性炭,充分搅拌45分钟;脱炭过滤;用0.23μm微孔滤膜过滤;冷冻干燥得无菌粉末,分装灌封。
实施例2药物组合物2
本发明实施例提供了一种用于治疗仔猪白痢的药物组合物,由以下重量份数的原料药材制成:黄荆子18重量份、马尾连33重量份、地锦草25重量份、墓头回34重量份、仙茅参16重量份、岩青兰31重量份、海金沙17重量份、水蓼22重量份、赤车使者34重量份、佩兰27重量份、仙鹤草42重量份、牛西西25重量份、紫菀34重量份、刺石榴40重量份、何首乌20重量份、土丁桂15重量份、牡荆叶30重量份、分心木22重量份、管仲34重量份、苘实12重量份、十大功劳叶28重量份和倒赤伞15重量份。
其制备方法如下:
第一步,将墓头回、仙茅参、岩青兰、海金沙、水蓼、赤车使者和佩兰按所述比例混合,用相对于获得的混合物质量的4倍的醇浓度为90%的乙醇溶解,加热回流3小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的2倍的醇浓度90%的乙醇溶解,加热回流2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为0.8g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为90%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将刺石榴、何首乌、土丁桂和牡荆叶按所述比例混合,加相对于获得的混合物质量的3倍的醇浓度90%的乙醇,加热回流提取2次,提取液合并,用管式离心机离心除杂,将除杂后的提取液于65℃的条件下减压浓缩至60℃时相对密度为1.22的膏体,将浓缩后的膏体用喷雾干燥器干燥成粉末;
第三步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的3倍的水溶解,加热煎煮3小时,过滤;将滤渣再次用相对于获得的混合物质量的1.5倍的水溶解,再次加热煎煮1.5小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第四步,将第一步、第二步和第三步获得的粉末混合,随后过筛成100目的细粉,将获得的细粉投入混合搅拌机中搅拌,即获得散剂。
药物组合物的毒性试验:
1、试验药物
选取黄荆子18g、马尾连33g、地锦草25g、墓头回34g、仙茅参16g、岩青兰31g、海金沙17g、水蓼22g、赤车使者34g、佩兰27g、仙鹤草42g、牛西西25g、紫菀34g、刺石榴40g、何首乌20g、土丁桂15g和牡荆叶30g混合,粉碎成粉末;将获得粉末加入1600g冷水中浸泡25小时,以文火煎煮,煎煮时间为1.5小时,将煎煮液过滤,获得第一滤液,收集滤渣;将过滤获得的滤渣再次加入1600g冷水中,以文火煎煮3次,每次煎煮1小时,过滤并合并过滤液,获得第二滤液;合并两次滤液,减压浓缩除去部分水,获得汤剂,汤剂的生药浓度为3g/ml。
2、试验方法:选用SD大鼠,给予不同浓度(18.0、6.0、2.0g生药/kg)的本发明的药物组合物的汤剂,每天灌胃一次,连续90天,末次给药后24小时各组活杀1/2动物(雌雄各半),其余1/2动物继续观察2周后活杀。试验期间观察动物的外观、一般行为、摄食量、体重变化,给药后90天和停药2周进行血液学(RBC、HB、网织红细胞、PLT、CT、WBC及分类)和血液生化(AST、ALT、ALP、Glu、BUN、Crca、TP、T.BIL、ALB、CHOL)、尿液生化、脏器系数、病理组织学等指标检查。试验结果表明:本发明的药物组合物在高、中、低剂量组动物一般状态良好,外观体征、行为活动、进食量和体重增长均无异常变化;三个剂量组及对照组血液学检查、血液生化学、尿液生化检查均在正常范围,组间无显著差异;各组主要脏器组织病理学检查未见明显异常。上述指标停药2周后也未见改变。本试验用药剂量分别为临床用药剂量的180、60、20倍,根据试验结果本发明的药物组合物在高、中、低三个剂量(18.0、6.0、2.0g生药/kg)连续90天给药对大鼠无明显影响,无明确的毒性靶器官和敏感指标,恢复期观察也未见延迟性毒性反应,提示本发明的药物组合物临床应用的剂量安全性较高。
对比试验
山东省德州市某猪养殖场,2013年12月底,发现将近450只28日龄仔猪出现不同程度的脱水、消瘦、皮肤苍白、精神委顿、食欲废绝、走路不稳、寒战,粪便为白色、黄白色,粥样、糊状,有腥臭味,有时粪便中混有气泡,肛门周围、尾及后肢常被稀粪沾污,喜钻卧垫料或挤压成堆,甚至出现死亡仔猪,将死亡仔猪解剖可见胃粘膜充血、水肿,肠内容物灰白色,酸臭,肠壁变薄半透明,肠粘膜充血、出血易剥脱,肠系膜淋巴结肿胀。根据上述流行病学和剖解诊断为猪白痢。选取28日龄确诊的患病仔猪180只,将180只患病猪随机分成三组,分别为实施例1组、实施例2组和对照组,三组的患病猪在体重、病情等方面均无显著差异,具有可比性。实施例1组、实施例2组和对照组分别使用本发明实施例1的粉针剂、实施例2的散剂和传统药物进行治疗;其中,粉针剂采用皮下注射,每次3g,每天一次,连续注射6天;散剂的使用方法是将散剂按照7g:570g的重量比例传统饲料中,连续饲喂6天;传统药物为皮下注射高免血清0.2毫升,饲喂传统饲料。实验周期为6天,实验前后分别称取各组患病猪体重,期间记录患病猪的痊愈情况及死亡数,计算出平均日增重及痊愈率,以及治愈数的时间比较,结果如表1,表2和表3所示。其中,治愈:体重恢复正常、精神活波、食欲正常、走路平稳,粪便颜色与同龄健康仔猪粪便颜色一样,没有腥臭味,肛门周围、尾及后肢没有稀粪沾污,行走和躺卧正常,抽样剖检胃粘膜,肠内容物,肠壁,肠粘膜,肠系膜淋巴结等组织器官正常;无效:临床症状没有改善甚至加重或死亡。
表1各组仔猪平均体重对照表
组别 | 总数 | 实验前平均体重 | 试验后平均体重 | 平均日增重 |
实施例1组 | 60只 | 5.8kg | 8.4kg | 0.43kg/d |
实施例2组 | 60只 | 5.6kg | 8.9kg | 0.55 kg/d |
对照组 | 60只 | 5.8kg | 6.2kg | 0.07kg/d |
从表1的数据可知:与对照组相比,使用本发明的药物组合物治疗患病仔猪,其平均体重比传统治疗方法治疗的仔猪分别高出2.2kg和2.7kg,平均日增重分别高出0.36kg/d和0.48kg/d。
表2各组仔猪的治疗效果对照表
组别 | 总数 | 痊愈数 | 无效数 | 痊愈率 |
实施例1组 | 60只 | 60只 | 0只 | 100% |
实施例2组 | 60只 | 60只 | 0只 | 100% |
对照组 | 60只 | 43只 | 17只 | 71.7% |
从表2的数据可知:与传统药物相比,本发明实施例1和2的药物组合物在治疗仔猪白痢方面具有疗效显著、价格低廉、无毒副作用的优势。
通过对比试验可知:与传统药物相比,本发明实施例1和2的药物组合物在治疗仔猪白痢方面具有毒副作用小、疗效显著的优势,而且还能够很好的保证仔猪的正常生长。
表3各组分别治疗6天后治愈数的时间比较例(%)
组别 | 例数 | 第1-2天 | 第3-4天 | 第5-6天 |
实施例1组 | 60 | (55)91.7% | (5)8.3% | (0)0% |
实施例2组 | 60 | (57)95% | (3)5% | (0)0% |
对照组 | 43 | (1)2.3% | (2)4.7% | (40)93% |
从表3的数据可知:本发明的药物组合物对治疗仔猪白痢,相对于传统药物在治疗效果上,具有显著的改进,明显缩短了治疗疗程。
典型病例:
2012年12月山东泰安某养猪专业户饲养的300只28日龄仔猪,将近100只仔猪出现不同程度的脱水、消瘦、皮肤苍白、精神委顿、食欲废绝、走路不稳、寒战,粪便为白色、黄白色,粥样、糊状,有腥臭味,有时粪便中混有气泡,肛门周围、尾及后肢常被稀粪沾污等症状,甚至出现死亡仔猪,将死亡仔猪解剖发现胃粘膜充血、水肿,肠内容物灰白色,酸臭或混有气泡,肠壁变薄半透明,肠粘膜充血、出血易剥脱,肠系膜淋巴结肿胀。立即将未出现症状的仔猪隔离出饲养场地。选取其中的50只患病仔猪,开始饲喂添加有本发明实施例2散剂的饲料,散剂按照7g:570g重量比混入传统饲料中,喂养6天,第1天患病仔猪症状明显改善,第2天50只仔猪均痊愈,继续饲喂4天后,与健康仔猪相比,平均体重增加。
以上所述仅为本发明的较佳实施例,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (10)
1.一种用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物包括以下原料药材:黄荆子、马尾连、地锦草、墓头回、仙茅参、岩青兰、海金沙、水蓼、赤车使者、佩兰、仙鹤草、牛西西、紫菀、刺石榴、何首乌、土丁桂和牡荆叶。
2.根据权利要求1所述的用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物中各原料药材的重量份数比为:黄荆子12-22重量份、马尾连15-35重量份、地锦草13-27重量份、墓头回17-36重量份、仙茅参14-28重量份、岩青兰15-32重量份、海金沙11-21重量份、水蓼14-24重量份、赤车使者15-35重量份、佩兰13-31重量份、仙鹤草15-45重量份、牛西西13-27重量份、紫菀14-36重量份、刺石榴15-40重量份、何首乌18-32重量份、土丁桂10-20重量份和牡荆叶12-42重量份。
3.根据权利要求1或2所述的用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物中各原料药材的重量份数比为:黄荆子18重量份、马尾连33重量份、地锦草25重量份、墓头回34重量份、仙茅参16重量份、岩青兰31重量份、海金沙17重量份、水蓼22重量份、赤车使者34重量份、佩兰27重量份、仙鹤草42重量份、牛西西25重量份、紫菀34重量份、刺石榴40重量份、何首乌20重量份、土丁桂15重量份和牡荆叶30重量份。
4.根据权利要求1-3任一项所述的用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物还包括:分心木、管仲、苘实、十大功劳叶和倒赤伞。
5.根据权利要求1-4任一项所述的用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物中各原料药材的重量份数为:黄荆子12-22重量份、马尾连15-35重量份、地锦草13-27重量份、墓头回17-36重量份、仙茅参14-28重量份、岩青兰15-32重量份、海金沙11-21重量份、水蓼14-24重量份、赤车使者15-35重量份、佩兰13-31重量份、仙鹤草15-45重量份、牛西西13-27重量份、紫菀14-36重量份、刺石榴15-40重量份、何首乌18-32重量份、土丁桂10-20重量份、牡荆叶12-42重量份、分心木15-25重量份、管仲13-37重量份、苘实10-20重量份、十大功劳叶12-34重量份和倒赤伞13-27重量份。
6.根据权利要求1-5任一项所述的用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物中各原料药材的重量份数为:黄荆子18重量份、马尾连33重量份、地锦草25重量份、墓头回34重量份、仙茅参16重量份、岩青兰31重量份、海金沙17重量份、水蓼22重量份、赤车使者34重量份、佩兰27重量份、仙鹤草42重量份、牛西西25重量份、紫菀34重量份、刺石榴40重量份、何首乌20重量份、土丁桂15重量份、牡荆叶30重量份、分心木22重量份、管仲34重量份、苘实12重量份、十大功劳叶28重量份和倒赤伞15重量份。
7.根据权利要求1-6任一项所述的用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物的剂型为粉针剂,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量3~5倍的醇浓度为85%~95%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在5℃~10℃的条件下静置24~36小时,采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎40~60分钟,获得0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料10g~20g,加入丙二醇30g~50g,加200ml注射用水,搅拌使其溶解,进一步加注射用水至1000ml,再加入1g~1.5g针用活性炭,充分搅拌30~50分钟;脱炭过滤;用0.22~0.24μm微孔滤膜过滤;冷冻干燥得无菌粉末,分装灌封。
8.根据权利要求1-6任一项所述的用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物的剂型为散剂,其制备方法包括以下步骤:
第一步,将墓头回、仙茅参、岩青兰、海金沙、水蓼、赤车使者和佩兰按所述比例混合,用相对于获得的混合物质量的3~5倍的醇浓度为85%~95%的乙醇溶解,加热回流2~4小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的1~2倍的醇浓度85%~95%的乙醇溶解,加热回流1~2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为0.7~0.9g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为90%~95%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将刺石榴、何首乌、土丁桂和牡荆叶按所述比例混合,加相对于获得的混合物质量的2~4倍的醇浓度85%~95%的乙醇,加热回流提取1~2次,提取液合并,用管式离心机离心除杂,将除杂后的提取液于60℃~70℃的条件下减压浓缩至60℃时相对密度为1.20~1.23的膏体,将浓缩后的膏体用喷雾干燥器干燥成粉末;
第三步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的2~4倍的水溶解,加热煎煮2~4小时,过滤;将滤渣再次用相对于获得的混合物质量的1~2倍的水溶解,再次加热煎煮1~2小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第四步,将第一步、第二步和第三步获得的粉末混合,随后过筛成80~120目的细粉,将获得的细粉投入混合搅拌机中搅拌,即获得散剂。
9.根据权利要求1-6任一项所述的用于治疗仔猪白痢的药物组合物,其特征在于,所述药物组合物的剂型为粉针剂,其制备方法包括以下步骤:
第一步,将所述原料药材按比例混合,放入超微粉碎机中粉碎成0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第二步,在第一步获得的混合粉料中加入相对于所述混合粉料的质量3~5倍的醇浓度为85%~95%的乙醇,搅拌溶解获得乙醇溶液,将乙醇溶液在5℃~10℃的条件下静置24~36小时,采用渗漉法以每分钟1~2ml的速度缓缓渗漉,收集渗漉液,浓缩并干燥,并在此放入超微粉碎机中粉碎40~60分钟,获得0.1~10μm体积平均粒径的微米级颗粒和粒径小于0.1μm体积平均粒径的纳米级颗粒组成的混合粉料,所述混合粉料的得粉率至少为95%;
第三步,取第二步获得的混合粉料10g~20g,加入丙二醇30g~50g,加200ml注射用水,搅拌使其溶解,进一步加注射用水至1000ml,再加入1g~1.5g针用活性炭,充分搅拌30~50分钟;脱炭过滤;用0.22~0.24μm微孔滤膜过滤;冷冻干燥得无菌粉末,分装灌封。
10.一种如权利要求1-6任一项所述的用于治疗仔猪白痢的药物组合物的制备方法,其特征在于,所述药物组合物的剂型为散剂,其制备方法包括以下步骤:
第一步,将墓头回、仙茅参、岩青兰、海金沙、水蓼、赤车使者和佩兰按所述比例混合,用相对于获得的混合物质量的3~5倍的醇浓度为85%~95%的乙醇溶解,加热回流2~4小时后提取,过滤,得第一过滤液;将滤渣再次用相对于获得的混合物质量的1~2倍的醇浓度85%~95%的乙醇溶解,加热回流1~2小时后提取,过滤,得第二过滤液;合并第一过滤液和第二过滤液,减压回收乙醇并浓缩至药液浓度为0.7~0.9g生药/mL,经体积为5L的大孔吸附树脂柱洗脱,先用5倍树脂柱体积的去离子水或蒸馏水洗脱,再用3倍树脂柱体积的醇浓度为90%~95%乙醇洗脱,收集乙醇洗脱液,减压浓缩除去乙醇,干燥并粉碎成粉末;
第二步,将刺石榴、何首乌、土丁桂和牡荆叶按所述比例混合,加相对于获得的混合物质量的2~4倍的醇浓度85%~95%的乙醇,加热回流提取1~2次,提取液合并,用管式离心机离心除杂,将除杂后的提取液于60℃~70℃的条件下减压浓缩至60℃时相对密度为1.20~1.23的膏体,将浓缩后的膏体用喷雾干燥器干燥成粉末;
第三步,将剩余原料药材按所述比例混合,加相对于获得的混合物质量的2~4倍的水溶解,加热煎煮2~4小时,过滤;将滤渣再次用相对于获得的混合物质量的1~2倍的水溶解,再次加热煎煮1~2小时,过滤;合并两次的过滤液,减压浓缩除去水分,干燥并粉碎成粉末;
第四步,将第一步、第二步和第三步获得的粉末混合,随后过筛成80~120目的细粉,将获得的细粉投入混合搅拌机中搅拌,即获得散剂。
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